Sr. Director Regulatory Compliance – Corporate (IRC1450)
This position is responsible for the development, implementation, maintenance, and monitoring of a regulatory and quality compliance program to ensure that the Companies of Integra LifeSciences are in conformance with national and international regulatory statutes and directives and governmental quality system regulations. Corporate policies and company compliance must meet the requirements of the Food and Drug Administration, International Standards of ISO 9001, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations and all other applicable regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The primary responsibility of the Sr. Director of Regulatory Compliance is to assure the divisions and companies of Integra LifeSciences are in conformance with national and international regulatory statutes and directives as well as governmental quality system regulations.
Assist the divisions and companies of Integra LifeSciences in maintaining full compliance with all applicable regulations and Integra Corporate policies.
Establish and implement Corporate Compliance audit programs.
Organize and implement Corporate Training Programs.
Provide analysis and timely reporting of key compliance trends and issues from Corporate audit program and/or corrective actions at each Division and Company.
Prepare Corporate Quality Management Review reports and coordinate Quality Management Reviews.
Coordinate with facilities and divisions quality management team for FDA inspections, ISO Audits and other Regulatory Agency audits, and manage communications with Notified Bodies and Regulatory Authorities regarding audit issues and audit responses.
Integrate company acquisitions as appropriate to the Integra LifeSciences Corporate Compliance System or ensure they are in compliance with appropriate regulatory statutes, regulations, and directives.
Establish Corporate Policies and procedures across all Integra LifeSciences divisions and companies to align compliance processes where necessary and where beneficial.
Assist in the development and implementation of effective compliance activities and monitor the implementation of actions taken as a result of audits providing management oversight and report on progress of actions taken.
Maintain up to date understanding of all issues and changes in regulatory compliance activities at FDA, European Economic Area, Japan and Rest of World compliance groups.
Manage the Corporate Document Management Process and supervise associates working on corporate documents.
Performs all other related duties as required.
DESIRED MINIMUM QUALIFICATIONS
Bachelors Degree in Science, Masters Degree preferred or other technically related field.
Masters Degree with 5 – 10 years experience or Bachelors Degree with 10 years experience.
Exceptional writing and interpersonal relationship skills.
Experience with direct contact with FDA and ISO Notified Bodies.
Proven track record of experience in Quality System Regulatory Compliance.
Knowledge of FDA Regulations, ISO 9001, ISO 13485:2003, Canadian Medical Device Regulation, Medical Device Directive and other National and International regulations and standards.
Demonstrated management skills and supervisory skills.
We are committed to creating an environment where all employees are valued and respected. We offer a competitive compensation/benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan. Please apply online at http://www.integra-ls.com to the “Sr. Director Regulatory Compliance-Corporate (IRC1450)” position.
No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V.
Integra LifeSciences is an Equal Opportunity Employer.
Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Integra has increased revenues over 40% annually over the last 10 years. We anticipate our significant growth to continue. In 2008 and 2009, Integra LifeSciences was named to the Forbes 200 Best Small Companies list. Our rapidly growing company of over 3000 employees is currently seeking a highly accomplished professional committed to taking us to even higher levels of growth and innovation. This position is located at our corporate headquarters in Plainsboro, New Jersey near Princeton.